Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Kiel
About this trial
The focus of the study is on patients Parkinson's disease showing as well behavioral disorders that can be described as pathological and are summarized under the term impulse control disorder (ICD). Changes in behavior and also pathological disorders are a common side effect of treatment for Parkinson's disease. The goal of this academic study is to compare the effect of surgical (deep brain stimulation, DBS) treatment combined with a coordinated and adapted best medical treatment (BMT) to be compared with the effect of optimized best medical treatment (BMT) alone. The stimulation arm (DBS+BMT) as well as the medication arm (BMT only) will be monitored according to clinical routine. Participants will have to agree to be randomly assigned to either deep brain stimulation in combination with the best medical treatment (DBS group) or the best medical treatment alone (BMT group). Participants will have to come regularly according to clinical routine to the clinic and complete various questionaires and scales for the study.
Eligibility criteria
Qualifiers
Age at the time of enrollment: ≤ 70 years
Diagnosis of PD according to MDS clinical diagnostic criteria
Onset of first PD motor symptoms ≥ 4 years
Moderate or severe impulse control disorder or related behavioral disorders according to Ardouin, with at least 1 score greater than or equal to 3 (or at least 2 scores greater than or equal to 2) on the Ardouin behaviour scale with the following items considered to reflect ICBDs or related behaviors: pathological gambling, hypersexuality, shopping, eating, hobbyism, punding and compulsive medication use
Disqualifiers
Surgical contraindications to undergo DBS operation
Ongoing severe depression (BDI-II > 28)
suicidal ideation (item 9 of BDI-II > 1)
Dementia (MoCA < 24) in the meds on condition
Trial design
Treatments tested in this trial
- bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment
- best medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group Recommendations
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Kiel
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Collaborator
Philipps University Marburg
Collaborator
University Hospital Schleswig-Holstein
Collaborator
Czech Technical University in Prague
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov